FDA.reportPublic FDA data

AN2300.50 Tyvek Pouch, 50 count

Primary DI
05060485030782
Brand
AN2300.50 Tyvek Pouch, 50 count
Company
ANDERSEN STERILIZERS INC.
Model
AN2300.50
Catalog number
AN2300.50
Device description
AN2300.50 Tyvek pouch
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200336000Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc.2020-11-12FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060485030782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060485030782050604850307825060485030782

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
336-376-3000faith.rios@sterility.com

Regulatory Flags#

DUNS number
931853006
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060485030683AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour ExposureAN1036.00AN1036.002023-08-31
05060485030676AN87 Dosimeter, Chemical IndicatorAN87.14AN87.142020-08-14
05060485030263AN85 EO Indicator, Type 1 Process IndicatorAN85.00AN85.002018-09-01
05060485030270AN86 EO Indicator, Type 1 Process IndicatorAN86.00AN86.002018-09-01
05060485030294AN1087 Dosimeter, Chemical IndicatorAN1087.00AN1087.002018-09-01
05060485030423AN1087 Dosimeter, Chemical IndicatorAN1087.16AN1087.162018-09-01
05060485030706AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115VAN4000.60AN4000.602023-08-31
05060485030713AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230VAN4000.61AN4000.612023-08-31
05060485030737AN4000.66 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 120VAN4000.66AN4000.662023-08-31
05060485030744AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230VAN4000.67AN4000.672023-08-31
05060485030607Anprolene AN75 Ethylene Oxide SterilizerAN75.64AN75.642020-08-14
05060485030614Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VAN75.65AN75.652020-08-14
05060485030621Anprolene AN75 Ethylene Oxide Sterilizer, 115VAN75.74AN75.742020-08-14
05060485030638Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VAN75.75AN75.752020-08-14
05060485030669Anprolene AN75 Refill Kit, 14 UnitsAN7514.00AN7514.002020-08-14
05060485030164 EOGas 4 Refill KitAN1004.00AN1004.002018-09-01
05060485030331AN1071 HumidichipAN1071.00AN1071.002018-09-01
05060485030393EOGas 4 Ethylene Oxide Gas SterilizerAN4000.01AN4000.012018-09-01
05060485030409EOGas 4 Ethylene Oxide Gas SterilizerAN4000.11 AN4000.11 2018-09-01
05060485030416EOGas 4 Sterilization BagAN1004.99AN1004.992018-09-01

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Primary DI, Brand, Company table
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20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
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00859464007731Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
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08404535030761Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
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